Protective effect of tomato pomace extract encapsulated in combination with probiotics against indomethacin induced enterocolitis.

Tomato pomace (TP), an antioxidant-rich byproduct, may be suitable for noble applications. The regulation of ROS generation and the anti-inflammatory response can help to prevent ulceration. The purpose of this study was to examine TP for antioxidants, in silico anti-inflammatory properties, and its potential to protect against ulceration and erosion triggered by indomethacin. Tomato pomace extract (TPE) was encapsulated either alone or with probiotics to maximize its potential effect. These microcapsules were investigated in indomethacin-treated rats. TPE demonstrated antioxidant activity as well as high levels of carotenoids (15 mg/g extract) and polyphenols. Because of their binding affinity as well as hydrophobic and hydrogen bond interactions with the active sites of TNF-α and IL-1ß inflammatory cytokines, ellagic acid and rutin may be implicated in the anti-inflammatory effect of TPE, according to the docking study. TPE microcapsules, either alone or in combination with probiotics, demonstrated a protective effect against enterocolitis by reducing oxidative stress and inflammation, as evidenced by the decrease in stomach and intestinal MDA, NO, IL-1ß, IL-6, and TNF-α levels and the increase in CAT, SOD, and GSH activities. The produced microcapsules are suggested to be promising candidates for protection against gastric ulcers and erosion.

Ligand-Screened Cerium-Based MOF Microcapsules Promote Nerve Regeneration via Mitochondrial Energy Supply.

Although mitochondria are crucial for recovery after spinal cord injury (SCI), therapeutic strategies to modulate mitochondrial metabolic energy to coordinate the immune response and nerve regeneration are lacking. Here, a ligand-screened cerium-based metal-organic framework (MOF) with better ROS scavenging and drug-loading abilities is encapsulated with polydopamine after loading creatine to obtain microcapsules (Cr/Ce@PDA nanoparticles), which reverse the energy deficits in both macrophages and neuronal cells by combining ROS scavenging and energy supplementation. It reprogrames inflammatory macrophages to the proregenerative phenotype via the succinate/HIF-1α/IL-1ß signaling axis. It also promotes the regeneration and differentiation of neural cells by activating the mTOR pathway and paracrine function of macrophages. In vivo experiments further confirm the effect of the microcapsules in regulating early ROS-inflammation positive-feedback chain reactions and continuously promoting nerve regeneration. This study provides a new strategy for correcting mitochondrial energy deficiency in the immune response and nerve regeneration following SCI.

Cumulative effects of exercise training and consumption of propolis on managing diabetic dyslipidemia in adult women: a single-blind, randomized, controlled trial with pre-post-intervention assessments.

Dyslipidemia is an imbalance of various lipids, and propolis, as a natural resinous viscos mixture made by Apis mellifera L. could improve in this condition. In this single-blind, randomized trial, 60 women with type 2 diabetes and dyslipidemia were divided into four groups: (1) the patients who did not apply the combined training and 500 mg propolis capsules supplement (Control group); (2) subjects performed combined training, including aerobic and resistance training (EXR); (3) subjects received the 500 mg propolis supplement capsules (SUPP); (4) Subjects performed combined training along with receiving the 500 mg propolis supplement capsules (EXR + SUPP). We evaluated the concentration of CTRP12, SFRP5, interleukin-6 (IL6), superoxide dismutase (SOD), malondialdehyde (MDA), adiponectin, and total antioxidant capacity (TAC) before and after the intervention. MDA, TAC, IL6, CTRP12, SFRP5 IL6, adiponectin, and lipid profile levels ameliorated in the EXR + SUPP group. We found that 8 weeks of treatment by combined exercise training and propolis supplement decreased inflammation activity and increased antioxidant defense in women with diabetic dyslipidemia.Trial registration This study was registered in the Iranian Registry of Clinical Trials; IRCT code: IRCT20211229053561N1.

The efficacy and safety of vibrating capsules for functional constipation: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Chronic constipation is a challenging functional gastrointestinal disorder that remains a global burden. Pharmacologic therapy, including laxatives and dietary fibers, are suggested as lines of treatment. Recent trials introduced an orally ingested vibrating capsule (VC) as an eligible option for chronic constipation management. METHODS: We conducted a literature search in English on electronic databases CENTRAL, PubMed, EMBASE, Scopus, and WOS until February 27th, 2023. RevMan was used to perform the meta-analysis. The results were reported as risk ratios (RRs), mean differences (MDs), and 95% confidence intervals (CIs). The study protocol was registered in PROSPERO with ID: (CRD42023409422). RESULTS: Three RCTs with a total of 601 patients were included in our analysis. There was no difference between the VC and placebo in responder rate (RR: 1.37 with 95% CI [0.82, 2.28], p = .22), CSBM change from baseline (MD: 0.21 with 95% CI [-0.26, 0.69], p = .38), SBM change from baseline (MD: 0.14 with 95% CI [-0.22, 0.49], p = .46), and the incidence of any adverse event (RR: 1.45 with a 95% CI of [0.79, 2.63], p = .23). However, VC was associated with increased vibration sensation (RR: 17.23, 95% CI [3.29, 90.20], p = .0008). CONCLUSIONS: VC was not effective to improve bowel movement in patients with functional constipation with no difference in response rate. However, evidence is still uncertain, with only three small RCTs that yielded heterogenous findings, mainly due to the different vibration protocols. Also, our findings suggest that VC is safe and well-tolerated, with no significant harmful effects observed. Therefore, more large-scale RCTs are needed to confirm the efficacy and safety of VC in patients with functional constipation, determining the most effective dose, frequency, and duration of treatment.

Clinical efficacy of one-finger meditation massage on IBS-C based on the "gut-brain axis" theory: study protocol for a randomized controlled trial.

BACKGROUND: As a common disorder of the gastrointestinal tract, irritable bowel syndrome (IBS) can have negative effects on patients and society, with irritable bowel syndrome with constipation(IBS-C) accounting for a large proportion of these effects. The main clinical manifestations of IBS-C are constipation, abdominal pain, and abdominal distension, which seriously impact the quality of life of patients. The mechanisms of IBS are complex, and the gut-brain axis has been an emerging and recognized theoretical system in recent years. Based on the theory of the gut-brain axis and the theory of Chinese medicine, we designed this study to evaluate the efficacy of one-finger meditation massage in treating IBS-C. METHODS/DESIGN: This is a randomized controlled trial. Eligible patients with irritable bowel syndrome (IBS-C) wererandomized 1:1 to a test group (massage plus probiotics) and a control group (probiotics). Patients in the test group weretreated once every 10 days for three consecutive courses of treatment (i.e., three months) and weregiven Bifidobacterium trifolium capsules 630 mg/dose three times daily 30 min after meals every day during the treatment period, with follow-up observations at the end of the third and sixth months of the treatment period. The control group weregiven Bifidobacterium trifolium capsules 630 mg/dose, 3 times a day for 3 months, with follow-up observations at the end of the third and sixth months of the treatment period. The primary outcome indicators are the concentrations of 5-HT and substance P and the IBS Severity Scale (IBS-SSS) assessment. Secondary outcomes are the Bristol Rating Scale (BRSA) score, the IBS Quality of Life Questionnaire (IBS-QOL scale) score, and the assessment of the effectiveness of the evidence. The results wereassessed at the pretreatment, posttreatment, and follow-up stages. Any side effects weresubject to assessment. DISCUSSION: The aim of this trial is to provide a new method of treatment based on pharmacological treatment that is easy to use, easy to promote and has proven efficacy and to establish the efficacy and safety of treating IBS-C through this trial. REGISTRATION FOR TRIAL: Chinese Clinical Trial Registry ChiCTR2200066417 on 5 December 2022. https://www.chictr.org.cn/bin/project/edit?pid=183461.

Evaluation of microbial and vancomycin treatments in ulcerative colitis in murine models.

BACKGROUND: Despite the number of available therapies for ulcerative colitis (UC), severe side effects and high cost has limited their clinical application. Thus, finding new alternative strategies with minimal side effects is inevitable. Therefore, this study aimed to compare the effectiveness of different therapeutic approaches in DSS-induced colitis. METHODS: Firstly, we designed oral bio-therapeutic products, Live Bacterial Products (LBP), which include a mixture of fecal bacteria strains isolated from healthy mice and prepared by microencapsulation and freeze-dried techniques. Then we investigated the efficiency of 7 days of freeze-dried FMT, LBP, and vancomycin treatments in DSS-induced colitis. Secondly, we compared the effect of 15 days of microbial therapies (freeze-dried powder of FMT and LBP microcapsules) and seven days of oral vancomycin on the severity of colitis in mice. Furthermore, the levels of IL-1ß and TNF-α were measured in serum by ELISA, and the fecal microbiota diversity was analyzed by high-throughput sequencing for all mice groups. RESULTS: After seven days of treatments, our results indicated that oral vancomycin reduced the severity of DSS-induced colitis in mice, where weight gain and a decrease in IL-1 ß and TNF-α levels were observed in the vancomycin group compared with other treatment groups. While after two weeks of treatment, the LBP microcapsules were able to reduce the severity of colitis. And at the end of the treatment period, weight gain and a decrease in the DAI scores and the levels of IL-1ß and TNF-α were noted in the LBP treatment group compared to other treatment groups. By high-throughput sequencing of the 16S rRNA gene, our results showed that while the microcapsules LBP treatment increased the fecal microbial diversity, after vancomycin therapy, most of the fecal microbiota genera and operational taxonomic units (OTUs) were depleted. CONCLUSION: Our results concluded that treatment duration and preparation methods affect the microbial therapies' efficiency in UC. Furthermore, this study highlighted the negative consequences of oral vancomycin administration on gut health that should be known before using this medication.

A randomized, active-controlled, parallel, open-label, multicenter, phase 4 study to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic pain.

BACKGROUND: Diabetic peripheral polyneuropathy is the most common chronic complication of type 2 diabetes. Neuropathic pain is challenging to manage, and various drugs are required to control it, decreasing treatment adherence. Pregabalin, a ligand that binds to alpha-2-delta subunits of the presynaptic calcium channel, has been approved by the Food and Drug Administration for the treatment of diabetic neuropathic pain. In this study, we will compare the efficacy, safety, treatment satisfaction, and compliance between pregabalin sustained-release (SR) tablets and pregabalin immediate-release (IR) capsules in type 2 diabetic patients with peripheral neuropathic pain. METHODS: This study is a randomized, active-controlled, parallel, open-label, multicenter, phase 4 clinical trial (trial registration NCT05624853). Type 2 diabetic patients with glycosylated hemoglobin below 10% and peripheral neuropathic pain who have been taking pregabalin 150 mg/d or more for more than 4 weeks will be randomly assigned to pregabalin SR tablet (150 mg once a day, n = 65) or pregabalin IR capsule (75 mg twice a day, n = 65) therapy for 8 weeks. The primary outcome will be the efficacy of SR pregabalin after 8 weeks of treatment, which will be assessed by visual analog scale measurements. The secondary outcomes will include changes in several parameters, such as quality of life, treatment satisfaction, quality of sleep, and drug compliance. DISCUSSION: In thus study, we aim to demonstrate that pregabalin SR tablets are associated with better compliance and satisfaction compared with pregabalin IR capsules, despite similar efficacy.

Standardised ido-BR1 Cucumber Extract Improved Parameters Linked to Moderate Osteoarthritis in a Placebo-controlled Study.

BACKGROUND: According to the World Health Organization, osteoarthritis (OA) is one of the 10 most disabling diseases in developed countries, with worldwide estimates of 9.6% prevalence in men and 18.0% in women over 60 years old. Its management is not well established and involves the use of high doses of painkillers coupled with anti-inflammatory agents. OBJECTIVE: In the search for alternatives to manage the disease, previous studies have shown superior properties of Q-ActinTM in managing OA-related pain compared with standard treatments. Qactin is a cucumber extract with the anti-inflammatory iminosugar idoBR1 standardised to over 1%. This study investigated the effects of different doses (20 mg, 100 mg) of Q-Actin in a longitudinal placebo-controlled experiment. METHODS: There were 101 patients with knee OA enrolled for the 180-day study, with 91 patients completing it. Patients were grouped into a placebo group (PLBO), as well as a 20mg dose (Q-Actin 1) and 100 mg dose (Q-Actin 2) groups. The PLBO group received cellulose in capsules identical to the Q-Actin capsules. RESULTS: There was a significant improvement in the pain-related parameters over time that was dose-dependent. CONCLUSION: This study clearly demonstrated the effectiveness of Q-Actin compared to placebo in the management of pain related to moderate osteoarthritis.

[Clinical and psychological manifestations of emotional burnout in mothers of children with neuropsychiatric diseases (on a model of ADHD)]. / Kliniko-psikhologicheskie proyavleniya emotsional'nogo vygoraniya u materei detei s psikhonevrologicheskimi zabolevaniyami (na modeli SDVG).

OBJECTIVE: To evaluate the therapeutic efficacy of Pantogam aktiv in the treatment of clinical manifestations of burnout in mothers of children with ADHD. MATERIAL AND METHODS: Under observation were 108 mothers of children with attention deficit hyperactivity disorder (ADHD) aged 25 to 50 years, who had symptoms of burnout in the clinical picture during the initial visit. The following research methods were used in the work: clinical history taking, neurological examination, S. Maslach questionnaire for assessing the burnout manifestations, subjective asthenia rating scale (MFI-20) with five subscales, digital fatigue rating scale (10-point variant), quantitative assessment of autonomic changes (questionnaire A.M. Wein), Spielberger-Khanin Scale for assessing emotional disorders, psychophysiological study of cognitive functions: test of attention variables TOVA (the Test of Variables of Attention). For the treatment of patients, the drug Pantogam Active was used in capsules of 300 mg, at a daily dose of 900 mg (2 capsules in the morning and 1 capsule in the afternoon) for 8 weeks. RESULTS: A re-examination after a course of treatment showed improvement in 68.5% of patients. After treatment, there was a significant decrease in the severity of such indicators of burnout as emotional exhaustion and depersonalization, a significant decrease in the average values according to the A.M. Wayne, a decrease in reactive anxiety, a statistically significant improvement in attention and a decrease in impulsivity (p<0.05). CONCLUSION: Thus, the results of the study indicate that the use of Pantogam active in the treatment of clinical manifestations of parental burnout is characterized by high efficiency. After treatment, there is a significant decrease in fatigue, asthenia, anxiety, and total indicators characterizing burnout. The data obtained make it possible to recommend the use of Pantogam aktiv in the treatment of clinical manifestations of parents burnout in children with neurological diseases.

Improved treatment of vulvovaginal candidiasis with Clotrimazole plus probiotic Lacidophilin Vaginal Capsules: A prospective, real-world study.

BACKGROUND: Clotrimazole has long been used to treat vulvovaginal candidiasis (VVC), yet the antibiotic resistance, adverse effects and recurrences still bring about a great challenge for the clinicians. To explore the effect of probiotic Lacidophilin Vaginal Capsules plus Clotrimazole Vaginal Tablets (500mg) in the treatment of uncomplicated VVC, a self-controlled real-world study was conducted. METHODS: Twenty-seven women with a normal vaginal flora and 15 women with uncomplicated VVC were recruited. The patients were treated with the single dose of Clotrimazole Vaginal Tablets (500mg) supplemented with 2 Lacidophilin Vaginal Capsules for the following 7 days. The patients were prospectively examined 4 times and the time points were at m0 (the first visit), m1 (8-10 days after the first visit), m2 (30 days after the second visit) and m3 (30 days after the third visit). However, women in the healthy normal control group were examined just once at the first visit. The obtained vaginal secretions were examined by high-throughput sequencing. RESULTS: The mean age in healthy control group and case group was 28.63 ± 5.40y and 27.67 ± 3.33y, respectively. Finally, 46.67% (7/15) of patients were cured at the second visit, 61.54% (8/13) were cured at the third visit and eventually 72.73% (8/11) were cured. A total of 81 samples were sequenced, generating 1668 operation taxonomy units among all the samples. The bacterial composition of women in the healthy control group was exceedingly abundant and dominated by Lactobacillus, especially by Lactobacillus. crispatus, and followed by Lactobacillus. iners, Lactobacillus. jensenii and Gardneralla. On the contrary, the bacterial composition of women with VVC was relatively few and dominated by Lactobacillus. iners. During the process of treatment, the bacterial abundance of VVC patients was increased gradually. At the final visit, the abundance of vaginal flora was augmented further with the dominant bacteria being Lactobacillus. crispatus, followed by Lactobacillus. iners. CONCLUSION: Clotrimazole Vaginal Tablets plus probiotic Lacidophilin Vaginal Capsules could improve the effect in treating uncomplicated VVC. This improved effect was achieved perhaps through improving the composition of vaginal flora and restoring vaginal microecology.

Levothyroxine: Conventional and Novel Drug Delivery Formulations.

Although levothyroxine is one of the most prescribed medications in the world, its bioavailability has been reported to be impaired by many factors, including interfering drugs or foods and concomitant diseases, and persistent hypothyroidism with a high dose of levothyroxine is thus elicited. Persistent hypothyroidism can also be induced by noninterchangeability between formulations and poor compliance. To address these issues some strategies have been developed. Novel formulations (liquid solutions and soft gel capsules) have been designed to eliminate malabsorption. Some other delivery routes (injections, suppositories, sprays, and sublingual and transdermal administrations) are aimed at circumventing different difficulties in dosing, such as thyroid emergencies and dysphagia. Moreover, nanomaterials have been used to develop delivery systems for the sustained release of levothyroxine to improve patient compliance and reduce costs. Some delivery systems encapsulating nanoparticles show promising release profiles. In this review, we first summarize the medical conditions that interfere with the bioavailability of oral levothyroxine and discuss the underlying mechanisms and treatments. The efficacy of liquid solutions and soft gel capsules are systematically evaluated. We further summarize the novel delivery routes for levothyroxine and their possible applications. Nanomaterials in the levothyroxine field are then discussed and compared based on their load and release profile. We hope the article provides novel insights into the drug delivery of levothyroxine.

Effect of external use of Qingluo San on clinical efficacy in patients with acute gouty arthritis.

OBJECTIVE: The present study aimed to observe the clinical efficacy of the external use of Qingluo San combined with diclofenac sodium double-release enteric capsules in the treatment of acute gouty arthritis (dampness-heat accumulation syndrome). METHODS: A total of 58 acute gouty arthritis patients were divided into two groups using the random number table method. Diclofenac sodium double-release enteric capsules were orally administered in the control group. Based on the treatment in the control group, the external use of Qingluo San was given in the treatment group, with 7-day course of treatment. The changes in visual analog scale (VAS) scores, the tenderness, swelling, and mobility function of the joint, and the traditional Chinese medicine (TCM) syndrome scores before and after the treatment, at day 0, 1, 3, 5 and 7, were observed in both groups, together with the comparison of laboratory indicators (erythrocyte sedimentation rate, ESR; C-reactive protein, CRP; uric acid, UA). RESULTS: The total effective rate was 96.55% in the treatment group and 82.76% in the control group. After treatment, the VAS score, the tenderness, swelling and function scores of the joint, and the TCM syndrome scores decreased in both groups. The treatment group was superior in improving the VAS scores, the tenderness, swelling and mobility function of the joint, and TCM syndrome scores, when compared to the control group (p < 0.05). The laboratory indicators, which included the ESR, CRP and UA, obviously decreased in both groups after treatment (p < 0.05). The ESR significantly decreased in the treatment group, when compared to the control group (p < 0.05). CONCLUSION: The combination of the external use of Qingluo San and oral administration of diclofenac sodium double-release enteric capsules can more rapidly relieve joint pain, and improve the clinical efficacy. This combination therapy also has certain advantages in relieving joint swelling and improving the mobility function of the joint. Hence, this is worthy of clinical promotion and application.

Rosemary as an adjunctive treatment in patients with major depressive disorder: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Rosemary has shown antidepressant and anxiolytic properties. Thus, the present study aimed at assessing the therapeutic effects of orally administered rosemary capsules in patients with major depressive disorder. MATERIALS AND METHODS: Rosmarinic acid content of rosemary was determined using high performance liquid chromatography method. Hard gelatin capsules of rosemary were prepared, and their physicochemical properties were assessed. In this clinical trial, patients with major depressive disorder were randomly divided into rosemary and control groups. They received one capsule of rosemary or placebo twice a day for 8 weeks. The anxiety subscale of Hospital Anxiety and Depression Scale and Beck Depression Inventory - Second Edition were respectively used to measure the symptoms of anxiety and depression in the patients before initiating the treatment and four and eight weeks after the treatment. RESULTS: The amount of rosmarinic acid in rosemary was found to be 21.13 ± 0.56 mg/g dried plant. The scores of anxiety subscale of Hospital Anxiety and Depression Scale and Beck Depression Inventory significantly decreased in the rosemary group compared to those in the control group 8 weeks after the treatment. Memory improvement was a beneficial side effect observed in the study. CONCLUSION: The use of rosemary as an adjunctive therapy could improve the symptoms of anxiety and depression in people with major depression.

Muscle Activity in Pre-Treatment and Post-Treatment Oral Submucous Fibrosis Patients: Electromyography Study.

Background: Oral submucous fibrosis (OSMF) is a premalignant condition of insidious onset which affects the oral mucosa, pharynx, and esophagus. The muscles of mastication are known to be affected resulting in limited mouth opening. Electromyography (EMG) is a sophisticated method of measuring and evaluating muscle activity. Previously, EMG was primarily utilized in medical sciences, but it is currently being used extensively in both the medical and dentistry fields. Objectives: The aim of the study is to evaluate the electromyographic activity of masseter muscle in OSMF patients before and after treatment and to compare with healthy controls. Materials and Methods: This prospective case-control clinical study comprised 180 OSMF patients who were divided into four groups and 45 healthy individuals served as the control group. The OSMF individuals were injected with hyaluronidase 1,500 IU mixed in 1.5 ml of dexamethasone and 0.5 ml of lignocaine HCL intralesionally twice a week for one month along with a basic physiotherapy regimen consisting of mouth exercises two times daily. The control subjects were given placebo capsules. The treatment was carried out for a month and the electromyographic masseter muscle activity was evaluated among the OSMF patients and control group before and after treatment. Results: The results revealed that the electromyographic activity of master muscles in OSMF patients showed increased activity when compared with healthy controls. Patients with OSMF showed decreased muscle activity after treatment. Conclusion: When compared with healthy controls, OSMF patients had higher electromyographic activity of the masseter muscles and the muscle activity was decreased following treatment. In OSMF patients, EMG may help in determining the involvement of the mastication and facial expression muscles. It can also be used as a diagnostic tool to assess the treatment outcome of muscle activity in OSMF patients.

Clinical study on the treatment of male infertility with Wuwei Fuzheng Yijing decoction based on microplastics: Study protocol for a randomized controlled trial.

BACKGROUND: Environmental pollution and male infertility have become global public health problems. The presence of microplastics (MPs) has been detected in the human body, and it has also been demonstrated that MPs can cause damage to the reproductive system. Wuwei Fuzheng Yijing Decoction (WWFZYJ) is effective in treating male infertility. Therefore, we designed a clinical randomized controlled trial to observe the effect of WWFZYJ on the content of MPs and semen quality in male infertility patients, and to evaluate its security. METHODS: In this randomized controlled study, 66 eligible patients were randomly assigned in a 1:1 ratio to a treatment group (WWFZYJ Decoction) and a control group (Coenzyme Q10 tablets combined with vitamin E soft capsules) for 8 weeks. The content of MPs in semen, sperm DNA Fragmentation Index (DFI), and semen analysis (including sperm density, sperm count, forward motile sperm, sperm motility, etc) will be used as primary indicators, and Traditional Chinese Medicine (TCM) syndrome scores will be used as secondary indicators. Vital signs (such as respiration, heart rate, body temperature, blood pressure, electrocardiogram, etc), blood routine, urine routine, stool routine, liver function, and renal function will be used as safety indicators. The primary and secondary indicators will be performed at 0th and 8th week, and the safety indicators will be performed at 0th, 4th, and 8th week. DISCUSSION: This study will provide evidence for the efficacy and safety of WWFZYJ in treating male infertility and reducing the content of MPs in semen, and further explore the effects of MPs on male fertility.

[The effectiveness of a probiotic containing Bifidobacterium longum BB-46 and Enterococcus faecium ENCfa-68 in the treatment of post-infectious irritable bowel syndrome. Prospective randomized comparative study].

BACKGROUND: In the treatment of post-infectious irritable bowel syndrome (PI-IBS), the leading role belongs to the normalization of the composition of the intestinal microbiome, the disturbances of which are associated with previous intestinal infections. AIM: To study the effectiveness of the drug Bifiform in the treatment of PI-IBS. MATERIALS AND METHODS: An open, prospective, comparative, randomized study included 62 patients with PI-IBS. The diagnosis was confirmed by the results of clinical, laboratory and endoscopic examination of the intestine and met the diagnostic criteria for IBS of the Rome Consensus IV. The patients were randomized into 2 groups depending on the therapy. The patients of the main group received an antispasmodic drug (mebeverin 200 mg 2 times a day or trimebutin 200 mg 3 times a day for 4 weeks), an antibiotic (rifaximin 400 mg 3 times a day or nifuroxazide 400 mg 2 once a day for 1 week), a drug that normalizes the consistency of feces (dioctahedral smectite or macrogol 4000) and Bifiform 2 capsules 2 times a day for 2 weeks. For patients of control group similar therapy was performed without the Bifiform. Evaluation of the effectiveness of treatment was carried out at the end of the course of therapy and 6 months after its termination. RESULTS: All included patients with PI-IBS had abdominal pain, flatulence and tenderness to palpation along the bowel, most of them had diarrhea. Disorders of the intestinal microbiota were detected in 77.4% of patients, while excessive bacterial growth in the small intestine occurred in 72.6%, disorders of the colon microbiocenosis with the presence of opportunistic bacteria in 62.9% of patients. A significant part of the patients had a combination of small and large intestinal dysbiosis. Histological examination of the colon mucosa showed signs of low degree of inflammation activity in all patients. The moderate increase in the level of fecal calprotectin was found in 62.2% of patients with colonic dysbiosis. The majority of patients in the main group showed a pronounced positive dynamics of clinical manifestations of the disease, restoration of the normal composition of the intestinal microbiota and normalization of the content of fecal calprotectin at the end of the course therapy. The good result was observed much more often in the main group at the end of the course of treatment and 6 months after its termination. CONCLUSION: The inclusion of Bifiform in the complex therapy of PI-IBS significantly increases its effectiveness both in arresting the clinical manifestations of the disease, and in restoring the normal composition of the intestinal microbiome and reducing the inflammatory process in the intestinal mucosa. In the majority of patients receiving Bifiform, the remission of the disease achieved at the end of the course of treatment and persisted even 6 months after its termination.

Integrative and complementary practices to control nausea and vomiting in pregnant women: a systematic review.

OBJECTIVE: to synthesize the evidence available in the literature on the effects of integrative and complementary practices in nausea and vomiting treatment in pregnant women. METHOD: a systematic review, reported according to PRISMA and registered in PROSPERO. The search for studies was carried out in 11 databases. To assess risk of bias in randomized clinical trials, the Cochrane Collaboration Risk of Bias Tool (RoB 2) was used. RESULTS: the final sample consisted of 31 articles, divided into three categories: aromatherapy, phytotherapy and acupuncture. It was observed that aromatherapy with lemon essential oil, ginger capsules, pericardial 6 point acupressure were the interventions that proved to be effective. Less than half of studies reported adverse effects, with mild and transient symptoms predominating. Most articles were classified as "some concern" in risk of bias assessment. CONCLUSION: the three most effective interventions to control gestational nausea and vomiting were aromatherapy, herbal medicine and acupuncture, with significant results in the assessment of individual studies.

The efficacy and safety of the Xuesaitong soft capsule in the treatment of patients with ischemic stroke: systematic review and meta-analysis.

BACKGROUND: Ischaemic stroke is a common neurological disease and a leading cause of severe disability and death in developed countries. In most cases, stroke is thought to be a multifactorial disorder or complex trait for which classic patterns of inheritance cannot be shown. Xuesaitong is one of the most commonly used medicines for treating ischemic stroke in China. However, compared to the conventional therapy, the effectiveness and safety of Xuesaitong for ischemic stroke needs to be further systematically reviewed and determined. METHODS: Relevant randomized controlled trials (RCTs) examining the use of the Xuesaitong soft capsule in the treatment of patients with ischemic stroke were identified from databases, including the China National Knowledge Infrastructure, Wanfang, PubMed, Embase, and Web of Science databases. Next, 2 researchers independently extracted information from the included studies, analyzed the data using STATA 15.0 software, and evaluated the quality of the included studies using RevMan 5.3. RESULTS: A total of 17 RCTs (comprising 1,942 patients with ischemic stroke) were included in the meta-analysis. The meta-analysis results showed that the Xuesaitong soft capsule treatment increased patients' total effective rate compared to conventional or other drug treatments, and improved patients' Clinical Severity Score (CSS scores) or Barthel index (BI) score. A further subgroup analysis stratified by different treatment times showed that Xuesaitong soft capsule treatment at 4 and 8 weeks improved CSS scores more than treatment at 2 weeks in patients with ischemic stroke. Additionally, the Xuesaitong soft capsule also significantly improved plasma viscosity, whole-blood viscosity at high and low shear rates, fibrinogen, hematocrit, and the effect on traditional Chinese medicine (TCM) single symptoms or signs in patients with ischemic stroke. DISCUSSION: In summary, compared to conventional or other drug treatments, the Xuesaitong soft capsule treatment was beneficial in improving patients' TCM symptoms (e.g., crooked mouth and tongue, and dizziness) and various indicators. Further, Xuesaitong soft capsule may be a safe and effective drug for the treatment of ischemic stroke. And large-scale randomized clinical trials are needed to further confirm our findings.